Stronger Warnings Added to Invokana Diabetes Medication

The U.S. Food and Drug Administration (FDA) has recently issued more severe warnings about the popular diabetes medication Invokana (canagliflozin) and an increased risk of amputation and other serious side effects including severe urinary tract infection, kidney failure, and heart attack.

Some of these injuries have resulted in a need for hospitalization and may have been life-threatening or resulted in permanent disability. Multiple Invokana lawsuits have been filed against Invokana’s manufacturer, Janssen Pharmaceuticals and the parent company, Johnson & Johnson (J&J). These lawsuits claimed that the drug company failed to warn patients and medical professionals about the dangers of the drug, according to drugwatch.com.

Invokana is a widely-used medication that helps control blood sugar in people with Type 2 diabetes. It also comes in a formula with metformin called Invokamet. These drugs belong to a class of drugs called SGLT2 inhibitors. The drugs work by passing excess sugar out of the body through urine. In 2015, J&J’s blockbuster drug brought in $1.3 million – approximately double what it made in 2014 – according to J&J’s Annual Report.

The FDA approved Invokana in 2013. In May 2015, the FDA warned Invokana could cause a buildup of acid in the blood called ketoacidosis, a condition that can be fatal. Then, in December of the same year, it announced the diabetes drug could also lead to blood infections and kidney injuries, reports drugwatch.com

The FDA has currently strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, the FDA has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk, reports FDA MedWatch.